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The American Journal of Nursing Aug 2020
Topics: Dimethylnitrosamine; Drug Contamination; Histamine H2 Antagonists; Humans; Ranitidine; Safety-Based Drug Withdrawals; United States; United States Food and Drug Administration
PubMed: 32732474
DOI: 10.1097/01.NAJ.0000694552.42987.b0 -
The Medical Letter on Drugs and... Nov 2010
Topics: Appetite Depressants; Cardiovascular Diseases; Cyclobutanes; Humans; Safety-Based Drug Withdrawals
PubMed: 21045763
DOI: No ID Found -
Journal of the American Veterinary... Nov 2010
Topics: Drug Industry; Drug Recalls; Legislation, Drug; Societies; United States; United States Food and Drug Administration; Veterinary Drugs; Veterinary Medicine
PubMed: 21073378
DOI: 10.2460/javma.237.10.1104 -
PDA Journal of Pharmaceutical Science... 2018INFARMED, the Portuguese national health authority, alerts the general public and health care professionals about quality or safety issues detected in health products.... (Review)
Review
INFARMED, the Portuguese national health authority, alerts the general public and health care professionals about quality or safety issues detected in health products. The present study analyses recalls of substandard medicines in Portugal between 2005 and 2015. All 338 alerts for medicine recalls were analysed, which represents a total of 378 drugs withdrawn. Despite the fact that the total number of medicine alerts has increased during the past decade, the number of actual medicine recalls remained relatively constant. The number of batches affected in each recall varies from only one to several batches. In addition, 294 of the alerts are related to voluntary recalls, that is, those initiated by the marketing authorisation holder, whereas only 40 were mandatory recalls. There are marketing authorisation holders that have had several medicine recalls over the period studied. The main cause of product recall was the pharmaceutical dosage form, followed by packaging problems. Forty-two percent of the withdrawn medicines are from solid oral forms, a value slightly higher than that obtained for the injectables group. Finally, substandard medicines have been accessible in the Portuguese market for a period that varied between one month and over four years. The data seem to show that the number of substandard medicines in Portugal has not been increasing. However, this may be due to a variety of causes, that is, better performance of the industry, non-detection of these cases, and so on. INFARMED, the Portuguese national health authority, alerts the general public and health care professionals about quality or safety issues detected in health products. The present study analyses market recalls of substandard medicines in Portugal between 2005 and 2015. All 338 alerts for medicine recalls were analysed, which represents a total of 378 drugs withdrawn. Despite the fact that the total number of medicine alerts has increased during the past decade, the number of actual medicine recalls has remained relatively constant. In addition, 294 of the alerts are related to voluntary recalls, that is, initiated by the marketing authorisation holder, whereas only 40 were mandatory recalls. There are marketing authorisation holders that have had several medicine recalls over the period studied. It was also found that substandard medicines have been accessible in the Portuguese market for a period that varied between 1 month and over 4 years. The data seem to show that the number of substandard medicines in Portugal has not been increasing. However, this may be due to a variety of causes, that is, better performance of the industry, non-detection of these cases, and so on.
Topics: Data Accuracy; Drug Industry; Drug Recalls; Humans; National Health Programs; Pharmaceutical Preparations; Portugal; Quality Control; Retrospective Studies
PubMed: 29030530
DOI: 10.5731/pdajpst.2017.007567 -
Expert Opinion on Investigational Drugs Oct 2011This perspective is a paper discussing drugs dropped from clinical development in the previous years. Specifically, this paper focuses on 16 cardiovascular drugs... (Review)
Review
This perspective is a paper discussing drugs dropped from clinical development in the previous years. Specifically, this paper focuses on 16 cardiovascular drugs discontinued in 2010 after reaching Phase I - III clinical trials. Information for this perspective is mainly derived from a search of Pharmaprojects.
Topics: Cardiovascular Agents; Clinical Trials as Topic; Drug Discovery; Drugs, Investigational; Humans; Product Recalls and Withdrawals; United States; United States Food and Drug Administration
PubMed: 21870899
DOI: 10.1517/13543784.2011.611500 -
Journal of Applied Microbiology Apr 2016The aim of this study was to describe the incidence of contamination of pharmaceutical products by melanized fungi and to consider control measures in relation to... (Review)
Review
The aim of this study was to describe the incidence of contamination of pharmaceutical products by melanized fungi and to consider control measures in relation to bioburden and cleanrooms. This study reviews and analyses pharmaceutical product recalls and offers incidence rates of fungal detection from a typical cleanrooms. The recalls include some serious cases which resulted in the loss of life. Of different types of fungal contamination incidences some of the most damaging have been due to melanized fungi ('black mould'), such as Exserohilum rostratum. The focus of the article is with melanized fungi. The study concludes that, from the review of recent pharmaceutical product recalls, fungal contamination is either increasingly common within cleanroom environments or the accuracy of sampling and the level of reporting has risen. The prevalence of melanized fungi in pharmaceutical facilities rests on specific virulence factors particular to these types of fungi, which are outlined. The article identifies a gap in the way that such fungi are screened for using available cultural methods. The article provides some control strategies, including assessing the suitability of disinfectants and biocides, for reducing the risk of melanized fungal incidences within the pharmaceutical facility. Understanding the fungal risk to pharmaceutical products remains a poorly understood and often overlooked aspect of pharmaceutical microbiology. This article helps to identify this risk and offer some guidance to those involved with pharmaceutical products manufacture in relation to bio-contamination control strategies.
Topics: Drug Contamination; Drug Industry; Drug Recalls; Fungi; Humans
PubMed: 26119714
DOI: 10.1111/jam.12888 -
British Dental Journal Feb 2010
Topics: Administration, Topical; Anti-Inflammatory Agents; Carboxymethylcellulose Sodium; Drug Combinations; Drug Industry; Humans; Marketing; Product Recalls and Withdrawals; Triamcinolone Acetonide
PubMed: 20147907
DOI: 10.1038/sj.bdj.2010.114 -
European Journal of Gastroenterology &... Dec 2021Ranitidine was one of the most commonly used medications for the treatment of gastroesophageal reflux disease. On 1 April 2020, the US Food and Drug Administration...
Ranitidine was one of the most commonly used medications for the treatment of gastroesophageal reflux disease. On 1 April 2020, the US Food and Drug Administration requested all manufacturers to immediately withdraw ranitidine from the market because of concern of higher than acceptable levels of N-nitrosodimethylamine, a potential carcinogen. Herein, we highlight the reason for this recall, along with the effects of this recall on both the patients and healthcare practitioners, and offer insights on management strategies.
Topics: Drug Recalls; Gastroesophageal Reflux; Humans; Ranitidine
PubMed: 33867447
DOI: 10.1097/MEG.0000000000002161 -
Lessons learned from postmarketing withdrawals of expedited approvals for oncology drug indications.The Lancet. Oncology Mar 2024In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).... (Review)
Review
In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Besides the EMA's conditional marketing authorisation programme and the FDA's Accelerated Approval Program, we observe a tendency towards fast approval for exploratory studies with non-randomised, uncontrolled designs and surrogate endpoints. This issue raises concerns about the robustness and effectiveness of accepted treatments, leaving patients and health-care professionals in a state of uncertainty. A substantial number of accelerated approvals have recently been withdrawn in the USA, with some still authorised in Europe, emphasising discrepancies in regulatory standards that affect both patients and society as a whole. We highlight examples of drugs, authorised on the basis of surrogate endpoints, that were later withdrawn due to an absence of overall survival benefit. Our findings address the challenges and consequences of accelerated approval pathways in oncology. In conclusion, this Policy Review calls for regulatory bodies to better align their procedures and insist on robust evidence, preferably through unbiased randomised controlled trials. Drug approval processes should prioritise patient benefit, overall survival, and quality of life to minimise risks and uncertainties for patients.
Topics: Humans; Drug Approval; Europe; Medical Oncology; Product Surveillance, Postmarketing; Safety-Based Drug Withdrawals
PubMed: 38423058
DOI: 10.1016/S1470-2045(23)00592-2 -
Postgraduate Medical Journal Feb 2011
Topics: Adverse Drug Reaction Reporting Systems; Drug and Narcotic Control; Drug-Related Side Effects and Adverse Reactions; Humans; Product Surveillance, Postmarketing; Randomized Controlled Trials as Topic; Safety-Based Drug Withdrawals
PubMed: 21303818
DOI: 10.1136/pgmj.2010.105064